This report by Coral Beach first appeared in Food Safety News and is reposted here with permission.
A whistle blower document regarding product safety at a plant that manufactured infant formula linked to a deadly, ongoing outbreak provides damning information against Abbott Nutrition, the maker of Similac and other popular formulas that have been recalled in relation to the outbreak.
The document, sent to top officials at the Food and Drug Administration in October 2021, sparked outrage from U.S. Rep. Rosa DeLauro who has already demanded information from the FDA regarding the Cronobacter outbreak among babies. DeLauro, D-CT, on April 28 shared a redacted version of the whistle blower complaint and renewed her criticism of FDA and Abbott Nutrition for their slow response to the outbreak in which at least four babies have been hospitalized, with two having died.
“I am deeply concerned about the practices at this Abbott facility and their apparent failure to implement and enforce internal controls at this facility. We need to know exactly who in the company was aware of this failure and the alleged attempts to hide this information from the FDA,” DeLauro said during a meeting on the Fiscal Year 2023 Budget Request for the United States Department of Agriculture.
“I am equally concerned that the FDA reacted far too slowly to this report. The report was submitted to the FDA on October 20, 2021. The FDA did not interview the whistleblower until late December 2021. According to news reports, FDA did not inspect the plant in person until January 31, 2022, and the recall was not issued until February 17, 2022.”
The FDA has found five strains of cronobacter at the Sturgis facility, but none match the outbreak strain. The discovery of the five types of cronobacter does however, suggest an ongoing problem at the facility and not just a single incident.
Information in the confidential whistle blower document was provided by a former employee who worked in the production plant in Quality Systems, a subunit of the Quality Assurance organization in Sturgis, MI, as part of Abbott’s Nutritional Division.
The whistle blower document outlines many problems at the Abbott production facility in Sturgis, MI, including the following:
- The Falsification of Records – On multiple occasions, and in various ways, records have been knowingly falsified. In most but not all of the situations, information of a material nature was not disclosed. This included testing seals on empty cans; signing verifications without adequate knowledge; understating or inaccurately describing events so as to limit or avoid oversight; issuing certifications of projection pages bereft of pertinent data; shipping packages with fill weights lower than represented on the labels; failing to maintain accurate maintenance records; and prematurely removing holds in the absence of all requisite approvals.
- Releasing Untested Infant Formula – The Sturgis site performed a time code removal after the discovery of microorganisms (“micros”) in a batch of infant formula. The remaining portion of the batch outside the time code removal was released without additional testing. On another occasion product was not re-called from the market even after management became aware of a nonconformity (“NC”).
- The 2019 FDA Audit – Active efforts were undertaken and even celebrated during and after the 2019 FDA audit to keep the auditors from learning of certain events believed to be associated with the discovery of micros in infant formula at the Sturgis site.
- Clean-in-Place Staffing and Practices – The Sturgis site has continued to permit lax practices associated with clean-in-place (“CIP”) procedures. The Sturgis site failed and continues to fail to have staff in place with sufficient training and experience to review CIP charts. Nor are CIP charts regularly reviewed prior to the release of a batch. CIP checklists do not require signatures of those performing the tasks and are not otherwise subject to audit by QS staff.
- Failure to Take Corrective Measures – The Sturgis site has repeatedly failed to undertake reasonable measures to reduce natural or unavoidable defects to the level feasible as mandated by the current Good Manufacturing Practices (“cGMPs”). Deficient testing procedures known to be prone to causing mistakes have not been corrected. The Sturgis site continues to rely on staff with insufficient training and experience to interact with third-party labs (“TPL”).
- Lack of Traceability – The Sturgis site has ongoing problems associated with the traceability of its products. The automatic labeler frequently failed to work properly and led to significant difficulties in retracing product. QS staff never knew with certainty if an affected pallet was retrieved.
The disclosure document was sent to top food safety officials and other leaders at FDA in October 2021. They included FDA’s top official, then-acting Commissioner Janet Woodcock, Susan Mayne, director of the Center for Food Safety and Applied Nutrition, Judy McMeekin, associate commissioner for Regulatory Affairs, and Catherine Hermsen, assistant commissioner of the agency’s Office of Criminal Investigations. The document was apparently not sent to FDA’s deputy director for food safety concerns, Frank Yiannas.
As of April 28 the FDA did not respond to a Food Safety News inquiry about the document. The agency did provide a statement indicating that its investigations into the outbreak and Abbott are continuing: “We know there have been questions about the timeline related to the Abbott Nutrition infant formula recall. However, this remains an open investigation with many moving parts. Our top priority is ensuring that any recalled product produced at the Sturgis, Mich. facility has been removed from the market. We are continuing to investigate and will continue to update our consumer alert should additional consumer safety information become available.”
Specific concerns raised in the document
The former employee says in the document that he repeatedly raised concerns with management at the plant and was routinely brushed aside and had his questions designated as “petty.”
“Ultimately, despite an admirable employment record at Abbott and elsewhere, complainant was terminated based upon his repeated elevation of compliance concerns. That termination is being investigated by OSHA after filing a whistleblower complaint under Section 42 of the Food Safety Modernization Act (FSMA complaint),” the document says.
“The timing of this complaint is prompted by the ongoing nature of the questionable practices and the fear of retaliation by employees who have raised concerns.”
One of the biggest problems — which has supported other failures in safety protocols at the plant — is the insistence by plant officials to continue to use paper records, according to the confidential document. Such records make product tracing, maintenance work, testing and other food safety measures much more difficult to conduct and use for data collection. And, according to the complainant, the paper records are easily and frequently falsified.
“A remaining and overriding concern is the rather dramatic evidence of inadequate internal controls. The delay in transitioning to electronic records; the absence of adequate procedures to protect employees raising concerns; the pervasive lack of accountability; the questionable incentive structure; and the ongoing failure to address a material contingent liability, among others, are endemic to inadequate internal controls where food safety is paramount. Abbott’s financial statements may also suggest regulatory concerns with respect to the inadequacy of its internal controls,” according to the document.
The concerns raised in the complaint have been corroborated by other Abbott employees, but fear of retaliation has kept them from coming forward individually.
“One report suggests a greater interest at the corporate level of identifying the sources of complaints as opposed to addressing the underlying concerns raised,” according to the whistle blower complaint.
Excerpts from the complaint filed under the Food Safety Modernization Act follow.
Suspected violations — The suspected violations may be categorized in a variety of ways. But regardless of category, the common thread was and is to conceal the reality of what is taking place at the Sturgis site. The violations are neither inadvertent nor minor in nature. They constitute acts of commission and omission by management. In either case, what has been concealed is, in a number of instances, material information and holds the prospect of putting the ultimate consumer at risk.
…the conduct was intentional and designed to conceal the reality of what was actually taking place at the Sturgis site.
Seams on packaging — The Sturgis site has had ongoing problems with seam integrity with powdered products. On an episodic basis, powder would become enmeshed in the seam thereby jeopardizing the integrity of the seal and product safety. Instead of addressing the underlying problem, the testing process was altered to test empty cans instead of sealed cans containing the product. To the Complainant’s knowledge, this questionable practice was never disclosed or referenced in records that came to his attention. He has reason to believe that the questionable practice has not ceased and, as well, has not been disclosed to FDA officials.
Complaints were made to management at the Sturgis site. Even members of Quality Assurance (QA) leadership were also reported to have expressed concerns to the Complainant. One member of QA leadership went so far as to suggest to Complainant the “criminality” of the decision to proceed in this manner.”
Serious regulatory breaches — It was not unusual for management to disregard situations involving severe breaches of the most basic regulatory requirements. In July of 2020, complainant became aware of projection pages missing test results associated with nine batches of product. For each batch, a projection page missing test results was approved by three analytical lab chemists and one QS auditor. In essence, the certifications as to the test results were patently false as the test results were not included.
Maintenance supervisors falsified records recharging root causes of problems. They also routinely blame others instead of addressing root causes.
For several years, some of the equipment associated with the drying process at the Sturgis site was failing and in need of repair. As a result, a number of product flow pipes were pitting and leaving pin holes. This allowed bacteria to enter the system and, at times, led to bacteria not being adequately cleaned out in clean-on-place washes. This, in turn, caused product flowing through the pipes to pick up the bacteria that was trapped in the defective pipe.
The 2019 FDA audit — During the 2019 FDA audit, it was generally known that the Sturgis site was worried what the FDA would find about the micro batches. Throughout the audit, QA leadership kept QS staff apprised. One member of management stated that the FDA was on the “right trail.” She even volunteered that she was amazed that the FDA was unable to discover what occurred with the micro batches.
Once the FDA audit was over, staff and department managers congratulated each other on a successful FDA audit. Complainant came to learn of a meeting where a senior QA official was understood to have admitted the awkwardness of having to avoid providing direct answers to questions asked by the FDA.
Records — Complainant became aware of what he reasonably believed was a practice of “sanitizing” files before furnishing them to auditors. It involved records being pulled and reviewed by management officials apart from where the auditors were located. He was also led to believe that some records were culled before furnishing a file to the auditors. Complainant does not know what actually took place. But he had and has concerns based upon what he observed in other contexts during his time at the Sturgis site.
In February of 2020, Complainant was explicit in raising concerns as to the efficacy of the testing procedure. He suggested that steps be taken to address the problems with the procedure so as to avoid a recurrence of what had happened to him as well as countless others within Abbott’s operations.
Testing of equipment — Despite the widely acknowledged deficiencies of the testing procedure, complainant’s suggestion for taking remedial action was rejected by management at the Sturgis site. No remedial action of any kind was suggested or even encouraged. Despite its widely-recognized deficiencies, the testing procedure continues to be used”
Interaction with third-party labs — The Sturgis site moved the responsibility for interacting with the third-party labs (TPLs) to Quality Systems. No one within QS had the same level of expertise as the staff of the analytical lab at the Sturgis site. Nor did the Complainant who was made responsible for interacting with the TPLs. He was repeatedly put in situations where he lacked adequate training and experience.
While Complainant tried to compensate for his lack of expertise by seeking input from the analytical lab, he was not qualified to address many of the complexities associated with the TPL. He repeatedly raised concerns with management as to his lack of training and experience. He suggested that, like the other division sites, it should be more competently handled by properly trained staff of the analytical labs.
Internal controls — In countless ways, Abbott has failed to implement and actively enforce adequate internal controls with respect to the Sturgis site. This failure does not appear to be limited to the Sturgis site. Officials at the division level were aware of many of the problems and failed to take corrective measures. Corporate policies and practices were and are clearly inadequate. Indeed, there is evidence that some officials at the division and corporate levels may also be complicit.
For reasons not entirely transparent, the proposed conversion away from paper records has been repeatedly deferred. One reason volunteered by one member of management to the complainant is that electronic records would make the Sturgis site more accountable to others at the division and corporate level. This same member of management has made the same comment to others, including well after the Complainant’s departure.
The ongoing reliance on paper records is suggestive of inadequate internal controls. This is especially so when management at the Sturgis site has repeatedly admitted a desire to keep division and corporate officials from being able to monitor its compliance with regulatory requirements. This need is ever-present with there being multiple episodes where management has consciously misled division officials as to … the seriousness of a situation.
Fear of retaliation pervades the Sturgis site — In a recent whistleblower investigation conducted by MIOSHA, the Michigan equivalent of OSHA, management identified in the presence of other staff the names of the individuals being questioned. Even at the corporate level, no meaningful steps were taken to protect the identity of witnesses or to protect against retaliation.
In another instance, the complainant confidentially reported an incident involving a stun gun. Others were told and “retaliation soon followed.”
Lack of accountability — As Complainant grew in experience and understanding of the operations at the Sturgis site, he became increasingly concerned as to the absence of accountability in terms of regulatory compliance. He spoke out. He believed the breadth of the lax practices put in jeopardy the safety of the product being produced. Consistent with 21 CFR § 117.110(a) and other regulatory provisions, he and others reasonably believed that Abbott was under a duty to minimize the likelihood of adulterated product.
Overlooking failure to follow good manufacturing practices — Discipline for failing to follow Abbott policies and cGMPs was selective. It was almost always overlooked when favored employees were involved.
Certainly employees who were part of management’s social network were largely if not entirely exempt from discipline. More than any other site, the Sturgis site was reputed to have the largest number of certificates of analysis (“COA”) returned for incompleteness or false information. Yet no one was held accountable for this ongoing practice.
Federal program liability — Certifications of compliance with FDA regulations, including cGMPs, are required to secure rebates under the Special Supplemental Nutrition Program for Women, Infants, and Children (“WIC Program”). The WIC Program provides federal grants to states for supplemental foods, health care referrals, and nutrition education for low-income pregnant, breastfeeding, and non-breastfeeding postpartum women, and to infants and children up to age five who are found to be at nutritional risk. Abbott is a major participant in the WIC Program.
Rebates are provided to manufacturers who supply infant formula for the program and are otherwise eligible.
As has been laid out in some detail in the foregoing, credible evidence exists to suggest that Abbott has for some time not fully complied with FDA regulations and 21 CFR part 106 in particular.
The regulations relating to the cGMPs appear to directly apply to many of the violations observed and reported by the Complainant and others at the Sturgis site. Abbott is a major beneficiary of rebates under the WIC program. To what extent it benefits from the $5 billion to$6 billion a year program is unclear. Yet the prospect of being terminated from the WIC program poses a material contingent liability. Given what the Complainant has reported, the veracity of certifications provided to federal and state officials are suspect.
Conclusions — Even though Abbott’s senior management is now aware of many of the alleged regulatory violations referenced in the foregoing, no serious effort to remedy the violations have been reported to date. Instead, the emphasis appears to be more focused on identifying current employees at the Sturgis site who may have reported concerns to the Complainant. Aside from the mandate of FDA regulations, Abbott’s inaction is directly at odds with the mandate of Sarbanes-Oxley mandating adequate internal controls and the Department of Justice’s policy mandating effective compliance programs.
Abbott’s inaction is also inconsistent with the Corporate Integrity Agreement that it entered into with the Office of Inspector General of the Department of Health and Human Services in May of 2012 as part of a plea agreement. United States v. Abbott Laboratories, No. 12-cr-00026 (W.D. Va., filed May 7, 2012). At the same time, Abbott also entered into settlement agreements with various states. Though not directly applicable to Abbott Nutrition, the core concepts apply in terms of the ongoing obligations on the part of Abbott’s management and board of directors.
It is further submitted that what is being reported is based upon the Complainant’s direct knowledge and, in a few instances, highly credible sources. Throughout his time at Abbott, and even since his departure, others have reported additional concerns that he was unable to verify. In countless situations, he was told by employees that the Sturgis site was like a “house of cards” if employees could speak freely. But the consensus remains that only with the intervention and protections of responsible enforcement officials would employees be inclined to speak freely.
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